title: Clinical and consumer trial performance of a sensitive immunodiagnostic home test that qualitatively detects low concentrations of sperm following vasectomy.
abstract: OBJECTIVE
  Compliance with post-vasectomy semen analysis could be improved with the availability of a simple, rapid and accurate home test. SpermCheck Vasectomy, a highly sensitive lateral flow immunochromatographic diagnostic device, was designed to detect extreme oligospermia or azoospermia in men after vasectomy. We report the results of clinical and consumer testing of SpermCheck.
  
  
  METHODS
  A prospective, noncomparative observational study assessed the ability of SpermCheck Vasectomy to predict post-vasectomy sperm counts obtained using a hemacytometer procedure based on standard World Health Organization methodology. Consumer studies evaluated ease of use.
  
  
  RESULTS
  A cohort of 144 post-vasectomy semen samples was tested in the clinical trial. SpermCheck was 96% accurate in predicting whether sperm counts were greater or less than a threshold of 250,000 sperm per ml, a level associated with little or no risk of pregnancy. Sensitivity was 93% (95% CI 79% to 98%) and specificity was 97% (91% to 99%). The positive predictive value of the test was 93% (79% to 98%), and most importantly the negative predictive value was 97% (91% to 99%). The test gave a positive result 100% of the time at sperm concentrations of 385,000/ml or greater. Consumer studies with 109 lay volunteers showed that SpermCheck was easy to use. Volunteers obtained the correct or expected test result in every case and the correct response rate on a 20 question survey about the test was 97%.
  
  
  CONCLUSIONS
  SpermCheck Vasectomy, a simple and reliable immunodiagnostic test that can provide evidence of vasectomy success or failure, offers a useful alternative to improve compliance with post-vasectomy sperm monitoring. It is currently the only Food and Drug Administration approved test for this purpose.
authors.affiliation: Department of Cell BiologyCenter for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia 22908-0732, USA.
authors.forename: Kenneth L
authors.initials: KL
authors.lastname: Klotz
authors.forename: Michael A
authors.initials: MA
authors.lastname: Coppola
authors.forename: Michel
authors.initials: M
authors.lastname: Labrecque
authors.forename: Victor M
authors.initials: VM
authors.lastname: Brugh
authors.forename: Kim
authors.initials: K
authors.lastname: Ramsey
authors.forename: Kyung-ah
authors.initials: KA
authors.lastname: Kim
authors.forename: Mark R
authors.initials: MR
authors.lastname: Conaway
authors.forename: Stuart S
authors.initials: SS
authors.lastname: Howards
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Flickinger
authors.forename: John C
authors.initials: JC
authors.lastname: Herr
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003258:Consumer Behavior; D004867:Equipment Design; D006801:Humans; D007159:Immunologic Tests / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013076:Sperm Count / Q000295:instrumentation*; D014659:Vasectomy; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic